Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT01171820
Description: There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01171820
Study Brief: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TAXUS® Liberté™ Patients receiving the TAXUS® Liberté™ stent during PCI None None 41 105 13 105 View
XIENCE V® EECSS Patients receiving the XIENCE V® EECSS stent during PCI None None 100 215 26 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Aortic valve stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.0 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial septal defect SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery dissection SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
In-stent coronary artery restenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial infarction, acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Tricuspid valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Catheter site haematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Catheter site related reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Noncardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Haematoma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Arteriovenous graft thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Instent coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Joint injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Vascular graft occlusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Cardiac stress test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Troponin T SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Diabetic foot SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Meniscus lesion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Brain neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Hepatic cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Hodgkins disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Leukaemia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Lip andor oral cavity cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Peritoneal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Cerebellar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Syncope vasovagal SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal artery stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Vocal cord disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Coronary angioplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Coronary arterial stent insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Coronary revascularisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Diabetes mellitus management SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Coronary artery dissection SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Femoral arterial stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypovolaemic shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Peripheral ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Retroperitoneal haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Vascular pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery dissection SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View